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Since there were a large number of spontaneous pregnancies, we also performed a per-protocol analysis as a secondary outcome. We calculated the per protocol analysis based on the people who completed all three cycles of IUI vs the people who completed one cycle of IVF.
Excluding the dropouts and the spontaneous conceptions, there were 18 live births from IUI (17 in the IUI group and one from those who withdrew from IVF and underwent IUI instead). 69 couples in the IUI group completed all three cycles of IUI and out of three couples who withdrew from IVF group and had IUI; only one completed all three cycles. Hence as per protocol, there were 18/70 (25.7%) live births per three cycles of IUI. There were 23 live births from 81 IVF cycles in the IVF group and 7 live births from 18 IVF cycles in the IUI group, 30/99 (30.3%) live births per cycle. According to per protocol analysis, three cycles of IUI had a similar live birth rate as one cycle of IVF, RR 1.17 (95% CI 0.71 – 1.93).
One of the main limitations of our trial is that we had to close our trial after recruiting 207 couples. This was a purely administrative decision, which was beyond the investigator’s control. Hence we report the results of the trial as they stand. We believe that the 95% confidence interval in our trial would have automatically taken into account the size of the trial.
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